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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - November 2011

  Generic Drug Name Generic Manufacturer Brand Name Approval Date
1 TIAGABINE HYDROCHLORIDE TALBETS, 2 MG AND 4 MG       SUN PHARMACEUTICAL INDUSTRIES, LTD. GABITRIL TABLETS 11/4/2011 
2 LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION, 0.5 MG/ML        SYNTHON PHARMACEUTICALS, INC. XYZAL ORAL SOLUTION, 0.5 MG/ML 11/7/2011 
3 MORPHINE SULFATE EXTENDED-RELEASE CAPSULES, USP 20 MG, 30 MG, 50 MG, 60 MG, 80 MG AND 100 MG   WATSON LABORATORIES, INC. KADIAN CAPSULES 11/10/2011 
4 EPROSARTAN MESYLATE TABLETS, 400 MG (BASE) AND 600 MG (BASE)       MYLAN PHARMACEUTICALS, INC. TEVETEN TABLETS 11/16/2011 
5 IMIPENEM AND CILASTATIN FOR INJECTION USP, (I.V.) 250 MG/250 MG (BASE) AND 500 MG/500 MG (BASE)       HOSPIRA INC. PRIMAXIN FOR INJECTION (I.V.) 11/16/2011 
6 IMIPENEM AND CILASTATIN FOR INJECTION USP, (I.V.) 500 MG/500 MG (BASE), PACKAGED IN SINGLE-DOSE INFUSION BOTTLES      HOSPIRA INC. PRIMAXIN FOR INJECTION I.V. 11/16/2011 
7 LAMIVUDINE TABLETS, 150 MG AND 300 MG       AUROBINDO PHARMA USA, INC. EPIVIR TABLETS 11/17/2011 
8 PHENYLBUTYRATE TABLETS, 500 MG        AMPLOGEN PHARMACEUTICALS, LLC BUPHENYL TABLETS 11/18/2011 
9 CARBOPLATIN INJECTION, 10 MG/ML; PACKAGED IN 1,000 MG/100 ML PHARMACY BULK PACKAGES      ONCO THERAPIES LIMITED PARAPLATIN INJECTION 11/23/2011 
10 GUAIFENESIN EXTENDED-RELEASE TABLETS, (OTC) 600 MG        PERRIGO R&D COMPANY MUCINEX EXTENDED-RELEASE TABLETS 11/23/2011 
11 ENOXAPARIN SODIUM INJECTION USP, 100 MG/ML; PACKAGED IN 300 MG/3 ML MULTIPLE-DOSE VIALS (WITH PRESERVATIVE)     SANDOZ INC. LOVENOX INJECTION 11/28/2011 
12 ATORVASTATIN CALCIUM TABLETS, 10 MG (BASE), 20 MG (BASE), 40 MG (BASE) AND 80 MG (BASE)     RANBAXY LABORATORIES LIMITED LIPITOR TABLETS 11/30/2011